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Thursday, April 21, 2011

Human Gene Patents: Privatization of our Species?

Human Gene Patents:

Privatization of our Species?

by Raul Soto-Velez

Human Genes : who should own them?

The practice of patenting genes has always been surrounded by controversy. The debate is framed by fundamental question such as: Are genes really patentable matter? Why should anyone “own” a gene? What are the scientific and economic consequences of patenting genes? What are the potential consequences of discontinuing this practice?

In a landmark 2010 decision, Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et al , Judge Robert Sweet of the United States District Court in Southern New York invalidated several patents owned by Myriad Genetics related to breast and ovarian cancer. In addition to casting doubt over the legality of existing patents that cover thousands of human genes, this decision has revived the debate over the desirability and legality of the practice of patenting genes, particularly human genes; the impact of this practice in public health, the advancement of science and research; and the financial importance of gene patents to the companies that hold them.

A very brief history of human gene patents

The USPTO has been granting patents for DNA sequences since 1980 (Foubister, 2000). In 1991, Dr. Craig Venter, from the National Institutes of Health (NIH) applied to patent 337 complementary human DNA sequences (Bluestone, 1991). Since then, over 20% of human DNA sequences have been patented (Jensen and Murray, 2005). All 20,000 to 25,000 human genes are now sequenced and in the public domain, after being mapped by the Human Genome Project (Landau, 2009). This means that the remaining genes are no longer considered as new or novel patentable matter.

Competing interests: Reasons for patenting human genes

Supporters of gene patents –mostly patent attorneys and owners of biotechnology companies– argue that eliminating gene patents would have a negative effect on the quality and quantity of scientific research and innovation. They assert that the exclusive rights over intellectual property granted by patents helps them attract investors. Without the monopoly provided by patents, they say, investors would be less likely to risk the large amounts of capital necessary to bring drugs or diagnostic tests to market. They also point out that patents promote disclosure and reduce secrecy, allowing all researchers access to the inventions (Schwartz, 2010) (Haun, 2010).

However, a study commissioned by the U.S. Department of Health and Human Services (Evans, 2010) disproves this assertion. The study found that for genes which were not covered by patents, such as cystic fibrosis and Huntington’s disease, multiple private and public laboratories were competing to develop products, a competition based on quality, innovation, and providing better services. In contrast, genes covered by patents were only studied by the institution holding the monopoly. For these genes the study found a totally different picture: no competition, and overall lower levels of quality and innovation.

Are human gene patents against scientific progress?

Article I, Section 8, Clause 8 of the United States Constitution establishes the purpose of patents as “to promote the progress of science and useful arts”. In the light of this definition, it is legitimate to question in which way, if any, do gene patents promote the progress of science.

In many ways, gene patents make it harder and more expensive for scientists and researchers to study genes and develop cures. The cost and complexity of determining which patents apply to one’s research, of licensing and paying royalties to holders of multiple overlapping patents (“patent thickets”), and the risk of bumping against someone else’s patented IP actually discourage researchers and companies that want to commercialize drugs, vaccines, or treatments related to the patented genes. This has the deleterious effect of inhibiting innovation (Van Overwalle, 2010) (Vince, 2002).

Gene patents make diagnostic tests for genetically-related health conditions less available to patients (due to exclusive licensing deals with a few laboratories), and more expensive (companies like Myriad charge a high license fee to the laboratories, plus a fee of $3,200 per each use, for their breast and ovarian cancer diagnostic tests). Both the reduced availability and the high cost make it harder for patients to get a second opinion (Foubister, 2000) (Salzberg, 2010). The American Medical Association has expressed concerns that patents on genes related to diseases may actually reduce the amount of diagnostic tests that are developed for genetic-related conditions (Foubister, 2000). In a survey by the University of Pennsylvania, 20% of the research laboratories surveyed stated that they declined to develop tests for a specific genetic condition because the gene for that condition was patented (Foubister, 2000).

In a challenge to gene patent owners, and assuming that the price for sequencing a person’s entire genome will drop significantly in the near future, scientists have developed do-it-yourself computational screens that allow an individual to screen his or her own genome for the presence of specific gene alleles, and have made the software available for free (Salzbert and Pertea, 2010).

Legal aspects: Legality of Gene Patents

Gene patents fail a number of important requirements for patentable matter.

·Chakrabarty: It is questionable whether existing gene patents meet the fundamental requirement for patentable subject matter established by the US Supreme Court in Diamond v Chakrabarty: “anything under the sun that is made by man”.

Naturally-occurring genes are not made by man, they are the product of millions of years of evolutionary processes such as natural selection. To get around this, Myriad’s patent claims refer not to the native DNA sequences in genes, but to DNA molecules isolated outside of the body. According to Myriad, this amounts to a “transformation”, meeting one of the tests for patentable matter under the machine-or-transformation test (transforming a particular article into a different state or thing) established by the US Court of Appeals for the Federal Circuit in In Re Bilski.

In small-molecule drugs, where changing a single atom can change the properties and biological function of a molecule, Myriad’s transformation rationale would likely be valid, and the product of the transformation would likely be patentable. But DNA is different. The inherent value of the DNA molecule is in the information it codifies, and this information does not change when the DNA is isolated. If this isolated DNA had really been “transformed” into a different state or thing, it would be useless as a diagnostic tool. Isolated DNA is useful precisely because it has exactly the same information as the native genes in the patient. At best, the identification and isolation of a gene and its function should be regarded as a discovery, not a patentable invention.

This scientific fact was recognized by Judge Sweet, when he affirmed that “the entire premise behind Myriad’s genetic testing is that the claimed isolated DNA retains, in all relevant respects, the identical nucleotide sequence found in native DNA” (Langreth, 2010). Furthermore, he asserted that isolated DNA “is not markedly different from native DNA as it exists in nature” (Van Overwalle, 2010), and considered Myriad’s transformation argument to be “a lawyer’s trick that circumvents the prohibition of the direct patenting of the DNA in our bodies, but which in practice reaches the same result” (Schwartz, 2010).

The United States Department of Justice agrees with this view. In an amicus curiae brief the Justice Department stated, among other things, that “the chemical structure of native human genes is a product of nature, and it is no less a product of nature when that structure is ‘isolated’ from its natural environment than are cotton fibers that have been separated from cotton seeds” (Salzberg, 2010).

In Re Bilski: The discovery of the relationship between certain mutations in the BRCA genes and breast and ovarian cancer is an abstract idea, and abstract mental processes fail the In Re Bilski test for patentable subject matters. These mutations occur in nature, and therefore are not patentable. In his decision, Judge Sweet declared that Myriad’s claim was an abstract mental process for comparing gene sequences (Hall et al, 2011), and therefore not patentable.

Utility: Another questionable aspect of gene patents is the practice of patenting gene fragments for which the full sequence and function is often not known (Haun, 2010) (Mayer, 2002). One of the requirements for a patent is to demostrate the utility of the invention. If the function of the claimed invention is unknown or poorly understood, the utility requirement cannot be satisfied, and those patents should be invalidated.

Legal aspects: potential outcomes of changing the law

Eliminating gene patents will not affect most patents related to biotechnology drugs or diagnostic tests. Genetically engineered protein molecules and organisms that do not exist in nature, which are the basis of most biotechnology drugs, are still patentable. Diagnostic tests that are based on non-obvious, novel methods are still patentable. Eliminating gene patents will force biotechnology companies to compete on the basis of creativity, innovation, and service, rather than depending on a monopolistic practices that shield them from competition.

Patenting genes and other basic discoveries in genetics has had great impact in public health and medical research – and not for the better.

The legality of gene patents is questionable, as they fail several fundamental patentable-matter criteria. The fundamental claim that supports gene patents –that isolated DNA is “transformed” and therefore “different” from native DNA in the body— has been rejected by a U.S. Federal Court and by the U.S. Department of Justice. Claims from patent lawyers and biotechnology company owners –parties that have a strong economic interest in maintaining the current gene patent paradigm– that without gene patents there will be less genetic research are contradicted by studies that show that the opposite is true.

Gene patents work against the express purpose of the U.S. patent system: to promote the progress of science and useful arts. They are used by companies to erect barriers that negatively impact research, discovery, and innovation. They hurt innovation by establishing monopolies that reduce or stifle competition; raise the cost of diagnostic tests and restrict their availability; and make it harder and more expensive for scientists to study genes and develop diagnostics, treatments, and cures.

13.United States Department of Justice, Brief for the United States as Amicus Curiae in Support of Neither Party, Association for Molecular Pathology, et al., v United States Patent and Trademark Office, et al., No. 2010-1406, in case no. 09-cv-4515.